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This was a multicenter, randomized, vehicle-controlled, double-blind parallel group study to evaluate the efficacy and safety of CD 2027 Oily Spray applied twice daily for 8 weeks in participants with plaque-type psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcitriol 3 mcg/g Spray | Experimental |
| |
| Calcitriol Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD 2027 | Drug | Participants applied Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Success Rate 1 (SR1) at Week 8 | Success Rate 1 was defined as percentage of participants who achieved at least 2-grade improvement from Baseline on Global Severity Score (GSS) at Week 8. GSS is a 5-point scale which ranges from 0-4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF). | Week 8 |
| Percentage of Participants With Success Rate 2 (SR2) at Week 8 | Success Rate 2 was defined as percentage of participants who achieved "clear" or "almost clear" on GSS at Week 8. GSS is a 5-point scale which ranges from 0-4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF). | Week 8 |
| Change From Baseline in Dermatologic Sum Score (DSS) at Week 8 | DSS is the sum of all the individual score of evaluated target lesion that includes plaque elevation (abnormal thickness of the psoriasis lesion), erythema (abnormal redness of the skin), and scaling (shedding of the stratum corneum). Each individual parameters evaluated the affected area by using a 5-point scale ranging from 0 to 4, that is, 0 = None; 1 = Mild; 2 = Moderate; 3 = Severe and 4 =Very severe, where higher score indicated worst condition. All missing values were imputed by last observation carried forward (LOCF). The total score of each parameter ranges from 0-12, where higher score indicated worst condition. | Baseline, Week 8 |
| Percentage of Participants With at Least 1-Grade Improvement From Baseline in Erythema, Scaling and Plaque Elevation | Erythema (abnormal redness of skin) score is a 5-point scale: 0=None (No detectable erythema. Skin of normal color); 1=Mild (Slight pinkness present); 2=Moderate (Definite redness, easily recognized); 3=Severe (Intense redness) and 4=Severe (Very Intense redness). Scaling (shedding of stratum corneum) score is a 5- point scale: 0=None (No shedding); 1=Mild (Barely perceptible shedding, noticeable only on light scratching or rubbing); 2=Moderate (Obvious but not profuse shedding); 3=Severe (heavy scale production) and 4=Very severe (very thick scales). Plaque elevation (abnormal thickness of psoriasis lesion) score was a 5- point scale: 0=None (Normal skin thickness. No elevation of skin); 1=Mild (Barely perceptible elevation (by touching) of psoriasis plaques); 2=Moderate (Obvious elevation above normal skin level; moderate thickening); 3=Severe (definite thick elevation above normal skin level) and 4=Severe (Very thick elevation). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States | ||
| Tennessee Clinical Research Center |
A total of 111 participants were screened in the study. Out of which, 88 participants were randomized to receive Calcitriol 3 micrograms per gram (mcg/g) spray or its vehicle.
The study was conducted at 6 centers in United States and Canada between 22 September 2008 and 23 January 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcitriol 3 mcg/g Spray | Participants applied Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks. |
| FG001 | Calcitriol Vehicle | Participants applied placebo matched to Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Intent-to-Treat (ITT) population is defined as all participants who were randomized and to whom medication is dispensed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcitriol 3 mcg/g Spray | Participants applied Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks. |
| BG001 | Calcitriol Vehicle | Participants applied placebo matched to Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Success Rate 1 (SR1) at Week 8 | Success Rate 1 was defined as percentage of participants who achieved at least 2-grade improvement from Baseline on Global Severity Score (GSS) at Week 8. GSS is a 5-point scale which ranges from 0-4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF). | ITT population is defined as all participants who were randomized and to whom medication is dispensed. | Posted | Number | percentage of participants | Week 8 |
|
up to Week 8
The Safety population is defined as all participants in the ITT population who have applied the study medication at least once.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcitriol 3 mcg/g Spray | Participants applied Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | +1 | Clinical.Studies@galderma.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
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| Calcitriol Vehicle | Drug | Participants applied placebo matched to Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks. |
|
| Baseline, Week 8 |
| up to Week 8 |
| Percentage of Participants With a Local Tolerability Score Worse Than Baseline Score | Local tolerability skin assessments were performed by the investigator and based on 5-point scale which ranges from 0 to 4. 0 = none (no evidence of local intolerance); 1=mild (minimal erythema and/or edema, slight glazed appearance); 2 = moderate (definite erythema and/or edema with peeling and/or cracking but needs no adaptation of posology); 3 = severe (erythema, edema glazing with fissures, few vesicles or papules) and 4 = very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions). Higher grades indicated worsening of condition. Percentage of participants with increase in score by Week 8 from baseline has been presented here, where the row titles indicate participant's new scores by Week 8. | up to Week 8 |
| Change From Baseline in Calcitriol Plasma Levels | Change from baseline in calcitriol plasma levels were reported. | Baseline, Week 8 |
| Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin | Change from baseline in serum calcium homeostasis parameter (Albumin) were reported. | Baseline, Week 8 |
| Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin-adjusted Calcium | Change from baseline in serum calcium homeostasis parameter (Albumin-adjusted calcium) were reported. | Baseline, Week 8 |
| Change From Baseline in Serum Calcium Homeostasis Parameter: Calcium | Change from baseline in serum calcium homeostasis parameter (Calcium) were reported. | Baseline, Week 8 |
| Change From Baseline in Serum Calcium Homeostasis Parameter: Phosphorus | Change from baseline in serum calcium homeostasis parameter (Phosphorus) were reported. | Baseline, Week 8 |
| Change From Baseline in Serum Calcium Homeostasis Parameter: Parathyroid Hormone (PTH) Intact | Change from baseline in serum calcium homeostasis parameter (PTH intact) were reported. | Baseline, Week 8 |
| Change From Baseline in Blood Chemistry: Alkaline Phosphatase, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) | Change from baseline in Blood Chemistry: Alkaline Phosphatase, AST and ALT were reported. | Baseline, Week 8 |
| Change From Baseline in Blood Chemistry: Bilirubin Direct, Bilirubin Total, Blood Urea Nitrogen (BUN) and Creatinine | Change from baseline in Blood Chemistry: Bilirubin Direct, Bilirubin Total, BUN and Creatinine were reported. | Baseline, Week 8 |
| Change From Baseline in Vital Sign Parameter: Heart Rate | Change from baseline in vital sign parameter: heart rate was reported. | Baseline, Week 8 |
| Change From Baseline in Vital Sign Parameter: Systolic Blood Pressure and Diastolic Blood Pressure | Change from baseline in vital sign parameter: Systolic Blood Pressure and Diastolic Blood Pressure was reported. | Baseline, Week 8 |
| Nashville |
| Tennessee |
| 37215 |
| United States |
| Stratica Medical | Edmonton | Alberta | T5K1X3 | Canada |
| Ultranova Skincare | Barrie | Ontario | L4M6L2 | Canada |
| North Bay Dermatology Centre | North Bay | Ontario | P1B3Z7 | Canada |
| K. Papp Clinical Research, Inc. | Waterloo | Ontario | N2J1C4 | Canada |
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Calcitriol Vehicle |
Participants applied placebo matched to Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks. |
|
|
| Primary | Percentage of Participants With Success Rate 2 (SR2) at Week 8 | Success Rate 2 was defined as percentage of participants who achieved "clear" or "almost clear" on GSS at Week 8. GSS is a 5-point scale which ranges from 0-4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF). | ITT population is defined as all participants who were randomized and to whom medication is dispensed. | Posted | Number | percentage of participants | Week 8 |
|
|
|
| Primary | Change From Baseline in Dermatologic Sum Score (DSS) at Week 8 | DSS is the sum of all the individual score of evaluated target lesion that includes plaque elevation (abnormal thickness of the psoriasis lesion), erythema (abnormal redness of the skin), and scaling (shedding of the stratum corneum). Each individual parameters evaluated the affected area by using a 5-point scale ranging from 0 to 4, that is, 0 = None; 1 = Mild; 2 = Moderate; 3 = Severe and 4 =Very severe, where higher score indicated worst condition. All missing values were imputed by last observation carried forward (LOCF). The total score of each parameter ranges from 0-12, where higher score indicated worst condition. | ITT population is defined as all participants who were randomized and to whom medication is dispensed. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 8 |
|
|
|
| Primary | Percentage of Participants With at Least 1-Grade Improvement From Baseline in Erythema, Scaling and Plaque Elevation | Erythema (abnormal redness of skin) score is a 5-point scale: 0=None (No detectable erythema. Skin of normal color); 1=Mild (Slight pinkness present); 2=Moderate (Definite redness, easily recognized); 3=Severe (Intense redness) and 4=Severe (Very Intense redness). Scaling (shedding of stratum corneum) score is a 5- point scale: 0=None (No shedding); 1=Mild (Barely perceptible shedding, noticeable only on light scratching or rubbing); 2=Moderate (Obvious but not profuse shedding); 3=Severe (heavy scale production) and 4=Very severe (very thick scales). Plaque elevation (abnormal thickness of psoriasis lesion) score was a 5- point scale: 0=None (Normal skin thickness. No elevation of skin); 1=Mild (Barely perceptible elevation (by touching) of psoriasis plaques); 2=Moderate (Obvious elevation above normal skin level; moderate thickening); 3=Severe (definite thick elevation above normal skin level) and 4=Severe (Very thick elevation). | ITT population is defined as all participants who were randomized and to whom medication is dispensed. | Posted | Number | percentage of participants | Baseline, Week 8 |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) | AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. | Posted | Count of Participants | Participants | up to Week 8 |
|
|
|
| Secondary | Percentage of Participants With a Local Tolerability Score Worse Than Baseline Score | Local tolerability skin assessments were performed by the investigator and based on 5-point scale which ranges from 0 to 4. 0 = none (no evidence of local intolerance); 1=mild (minimal erythema and/or edema, slight glazed appearance); 2 = moderate (definite erythema and/or edema with peeling and/or cracking but needs no adaptation of posology); 3 = severe (erythema, edema glazing with fissures, few vesicles or papules) and 4 = very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions). Higher grades indicated worsening of condition. Percentage of participants with increase in score by Week 8 from baseline has been presented here, where the row titles indicate participant's new scores by Week 8. | The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. | Posted | Number | percentage of participants | up to Week 8 |
|
|
|
| Secondary | Change From Baseline in Calcitriol Plasma Levels | Change from baseline in calcitriol plasma levels were reported. | The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | picograms per milliliter (pg/mL) | Baseline, Week 8 |
|
|
|
| Secondary | Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin | Change from baseline in serum calcium homeostasis parameter (Albumin) were reported. | The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | grams per deciliter (g/dL) | Baseline, Week 8 |
|
|
|
| Secondary | Change From Baseline in Serum Calcium Homeostasis Parameter: Albumin-adjusted Calcium | Change from baseline in serum calcium homeostasis parameter (Albumin-adjusted calcium) were reported. | The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | Baseline, Week 8 |
|
|
|
| Secondary | Change From Baseline in Serum Calcium Homeostasis Parameter: Calcium | Change from baseline in serum calcium homeostasis parameter (Calcium) were reported. | The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Week 8 |
|
|
|
| Secondary | Change From Baseline in Serum Calcium Homeostasis Parameter: Phosphorus | Change from baseline in serum calcium homeostasis parameter (Phosphorus) were reported. | The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Week 8 |
|
|
|
| Secondary | Change From Baseline in Serum Calcium Homeostasis Parameter: Parathyroid Hormone (PTH) Intact | Change from baseline in serum calcium homeostasis parameter (PTH intact) were reported. | The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure | Posted | Mean | Standard Deviation | pg/mL | Baseline, Week 8 |
|
|
|
| Secondary | Change From Baseline in Blood Chemistry: Alkaline Phosphatase, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) | Change from baseline in Blood Chemistry: Alkaline Phosphatase, AST and ALT were reported. | The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | international units per liter (IU/L) | Baseline, Week 8 |
|
|
|
| Secondary | Change From Baseline in Blood Chemistry: Bilirubin Direct, Bilirubin Total, Blood Urea Nitrogen (BUN) and Creatinine | Change from baseline in Blood Chemistry: Bilirubin Direct, Bilirubin Total, BUN and Creatinine were reported. | The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Week 8 |
|
|
|
| Secondary | Change From Baseline in Vital Sign Parameter: Heart Rate | Change from baseline in vital sign parameter: heart rate was reported. | The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | beats per minute | Baseline, Week 8 |
|
|
|
| Secondary | Change From Baseline in Vital Sign Parameter: Systolic Blood Pressure and Diastolic Blood Pressure | Change from baseline in vital sign parameter: Systolic Blood Pressure and Diastolic Blood Pressure was reported. | The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | Baseline, Week 8 |
|
|
|
| 0 |
| 44 |
| 1 |
| 44 |
| 10 |
| 44 |
| EG001 | Calcitriol Vehicle | Participants applied placebo matched to Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks. | 0 | 44 | 1 | 44 | 8 | 44 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Blood calcium increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
Not provided
| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| Plaque elevation |
|
| 3 = severe |
|
| 4 = very severe |
|
| ALT |
|
| BUN |
|
| Creatinine |
|